Qa Ra Compliance Specialist

5 days ago

Saint Petersburg, United States ProQualityNetwork Full time
Job DescriptionJob Description

Title: QA/RA Compliance Specialist (14314057)

Location: St. Petersburg, FL 100% Onsite Work

DURATION: Approximately 6 Months and may extend

SHIFT: MON-FRI 8AM - 5PM OR 9AM - 6PM.

Positions: 1.


Education or Equivalent:

Bachelors Degree in Science or related field required (Chemistry, Microbiology or Biology);

A minimum of 3 years related experience in the pharmaceutical manufacturing industry.

Strong background working with Change Controls and management of change control processes.


Basic Function:

This position is responsible for quality and regulatory affairs services, including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints; preparing annual product reviews, tracking and trending, and follow-up of the Change Control and CAPA programs. This position interacts directly with manufacturing, engineering, product development, technical services, validation, etc personnel and is responsible for the quality/regulatory feedback loop to those impacted areas. Also, this position will involve preparing filings to support site registrations and permits as well as regulatory submissions to the FDA, FL DBPR, and other worldwide agencies as needed to support Customer filings under the direction of the Supervisor. In support of this activity, this position will review change control notifications of all types to determine the impact on regulatory filings. Furthermore, this position will participate in the internal audit program.


Specific Activities and Responsibilities:

Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required

Prepare and submit all federal, state, and local permits in a timely manner

Interact with Customers and gather information as needed to support registration activities

Provide regulatory impact assessment on all change controls as required

Assist in the preparation of standard operating procedures (SOPs) associated with the job function; review and approve SOPs requiring regulatory function participation under the direction of the Group Leader

Assist in regulatory/health authority audits collecting information as requested

Collaborate with Subject Matter Experts (SMEs), management, and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues, and working jointly towards resolution

Prepare APRs in accordance with site procedures and timelines.

Prepare complaint investigation reports and work closely with others on site events to verify the scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on-time closure.

Assess product complaints and APR trends, provide guidance and collaborate on plans of action to address trends as per site SOPs.

May author other types of quality system documents as directed or assigned by QA management.

Liaise with customers to ensure customer requirements are satisfied.

Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking, trending, and closure

Author/compile monthly, quarterly and annual summaries and metrics

Other duties as required in support of Catalent Pharma Solutions high performance, such as but not limited to, assisting site management in driving and enforcing cGMPs; mentoring other individuals within the organization in compliance; participating in Internal Assessments; facilitating routine compliance and CAPA Review Board meetings, including follow-up actions; facilitating and conducting training.


  • QA/ra Compliance Specialist

    1 week ago

    Saint Petersburg, United States Automated Systems Inc. Full time

    **QA/RA Compliance Specialist** **Location**: St. Petersburg, FL - Onsite **Contract**: 3-4-month duration with possible extensions **Shift**: Monday - Friday, 8am-5pm **Job Role Summary**: This position is responsible for quality and regulatory affairs services, including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests,...

  • QA/RA Compliance Specialist

    7 days ago

    Saint Petersburg, United States IMS People Full time

    Job DescriptionJob DescriptionJob Title: QA/RA Compliance SpecialistJob Location: St. Petersburg, FLDuration: 6 months on w2Shift Timing: Mon- Fri 8AM, OR 9AM - 6PMDescription:This position is responsible for quality and regulatory affairs services, including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and...

  • QA/RA Compliance Specialist

    7 days ago

    St. Petersburg, United States Zolon Tech Solutions, Inc. Full time

    Title : QA/RA Compliance Specialist Location : St. Petersburg, FL Duration : 6 Months Job Description: Quality AND Documentation AND (Regulatory OR Submissions OR SOP) AND (CAPA OR "Corrective Action" OR "Change Control") Required Skills/Experience: A minimum of 3 years related experience in the pharmaceutical manufacturing industry. Strong background...

  • QA / RA Compliance Specialist

    7 days ago

    St. Petersburg, United States Joulé Full time

    Job Title: QA / RA Compliance Specialist Location: St. Petersburg, FL Schedule / Hours: Monday - Friday, 8am - 5pm or 9am - 6pm, onsite Type: Temp Responsibilities Preparation and submission of ANDA / NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports);...

  • QA / RA Compliance Specialist

    5 days ago

    St Petersburg, United States System One Holdings, LLC Full time

    Job Title: QA / RA Compliance Specialist Location:St. Petersburg, FL Schedule / Hours: Monday - Friday, 8am - 5pm or 9am - 6pm, onsite Type: Temp Responsibilities: Preparation and submission of ANDA / NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant / site...

  • QA / RA Compliance Specialist

    7 days ago

    St. Petersburg, United States Joulé Full time

    Job Title: QA / RA Compliance Specialist Location: St. Petersburg, FL Schedule / Hours: Monday - Friday, 8am - 5pm or 9am - 6pm, onsite Type: Temp Responsibilities: Preparation and submission of ANDA / NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual...

  • QA RA Compliance Specialist

    3 days ago

    St Petersburg, United States Manpower Engineering Full time

    We have partnered with a leader in the pharmaceuticals and biologics industry. We are currently seeking a contract QA Compliance who possesses a strong background in pharmaceutical manufacturing. This is a great opportunity with a company that has a strong culture and room for growth. Job Title: QA RA Compliance Specialist Location: St Petersburg FLPay...

  • QA/RA Compliance Specialist

    4 days ago

    St Petersburg, United States The Fountain Group Full time

    Currently I have an opening for a QA/RA Compliance Specialist located in St. Petersburg, FL. Details for the position are as follows:Job Description:Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files;...

  • QA/RA Compliance Specialist

    2 days ago

    St Petersburg, United States The Fountain Group Full time

    Currently I have an opening for a QA/RA Compliance Specialist located in St. Petersburg, FL. Details for the position are as follows: Job Description: Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files;...

  • Contract QA/ra Compliance Specialist

    1 week ago

    Saint Petersburg, United States Medvacon Life Sciences Full time

    PAY - $30/HR ONSITE - DURATION - 3-4 MONTHS AND MAY EXTEND - SHIFT - MON-FRI 8AM - 5PM OR 9AM - 6PM. Education or Equivalent: - Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology); - A minimum of 3 years related experience in the pharmaceutical manufacturing industry. - Strong background working with Change Controls...

  • QA/RA Compliance Specialist

    7 days ago

    Saint Petersburg, United States Aditi Consulting Full time

    Education or Equivalent: Bachelor’s degree in science or related field required (Chemistry, Microbiology or Biology); A minimum of 3 years related experience in the pharmaceutical manufacturing industry. Strong background working with Change Controls and management of change control processes. Basic Function: This position is responsible for quality...

  • Contract QA/RA Compliance Specialist

    7 days ago

    Saint Petersburg, United States Medvacon Life Sciences Full time

    Job DescriptionJob DescriptionPAY - $30/HRONSITE - DURATION - 3-4 MONTHS AND MAY EXTEND - SHIFT - MON-FRI 8AM - 5PM OR 9AM - 6PM.Education or Equivalent:Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology);A minimum of 3 years related experience in the pharmaceutical manufacturing industry.Strong background working...

  • QA/RA Compliance Specialist

    2 months ago

    St. Petersburg, United States Infojini Full time

    • Prepare and submit all federal, state and local permits in timely manner • Interact with Customers and gather information as needed to support registration activities • Assist in the preparation of standard operating procedures (SOPs) associated with job function; review and approve SOPs requiring the regulatory function participation under direction...

  • QA/RA Compliance Specialist

    7 days ago

    St Petersburg, United States Aditi Consulting Full time

    Education or Equivalent: Bachelor’s degree in science or related field required (Chemistry, Microbiology or Biology); A minimum of 3 years related experience in the pharmaceutical manufacturing industry. Strong background working with Change Controls and management of change control processes. Basic Function: This position is responsible for quality and...

  • QA/RA Compliance Specialist

    6 days ago

    St Petersburg, United States Aditi Consulting Full time

    Education or Equivalent: The following information aims to provide potential candidates with a better understanding of the requirements for this role. Bachelor’s degree in science or related field required (Chemistry, Microbiology or Biology); A minimum of 3 years related experience in the pharmaceutical manufacturing industry. Strong background working...

  • Regulatory Compliance Specialist

    5 days ago

    St Petersburg, United States Infojini Inc Full time

    Job Title – QA/RA Compliance SpecialistLocation – St. Petersburg, FL 33716Duration – 6+ months contract positionShift Hours – Monday – Friday 8AM – 5PM OR 9AM – 6PMJob Description• This position is responsible for quality and regulatory affairs services, including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP...

  • QA Compliance Specialist II

    2 weeks ago

    Petersburg, United States Civica Rx Full time

    About Civica:Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile...

  • IME QA Specialist

    4 weeks ago

    Saint Petersburg, United States Ethos Risk Services Full time

    Job DescriptionJob DescriptionJob DescriptionThe IME QA Specialist is responsible for ensuring case reports are of the highest quality and integrity and in full compliance with client contractual agreement, regulatory agency standards and /or federal and state mandates.Responsibilities· Performs quality assurance review of peer review reports,...

  • IME QA Specialist

    3 weeks ago

    Saint Petersburg, United States Ethos Risk Services Full time

    Job DescriptionJob DescriptionJob DescriptionThe IME QA Specialist is responsible for ensuring case reports are of the highest quality and integrity and in full compliance with client contractual agreement, regulatory agency standards and /or federal and state mandates.Responsibilities· Performs quality assurance review of peer review reports,...

  • QA Compliance Specialist II

    2 weeks ago

    Petersburg, United States Civica Rx Full time

    About Civica:Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly...